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The Ongoing Challenges of Applying QbD to Biopharmaceutical Products

By: Howard L. Levine, Ph.D., Susan Dana Jones, Ph.D., and Alex D. Kanarek, Ph.D.
Reprinted with permission of BioProcess International, January 2011

How best to apply the concept of Quality by Design to biopharmaceutical products continues to be conundrum for biotech companies. A recent FDA-commissioned study by McKinsey & Co. finds that the industry is embracing QbD but FDA is struggling with internal confusion and disagreement over how QbD should be applied to biotech products and what type of data should be required to define a biotech design space. To facilitate broader acceptance and implementation of QbD, FDA must clarify exactly what data and how much they expect to support QbD-based submissions. Until such guidance is provided, companies will continue to struggle and QbD will not achieve its fullest potential.